吉利德科學 (GILD) 2011 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by.

And welcome to the Gilead Sciences' fourth-quarter 2011 earnings conference call.

My name is Stacy and I will be your conference moderator for today.

At this time, all participants are in a listen-only mode.

Later, we will conduct a question-and-answer session.

As a reminder, this conference call is being recorded today, February 2, 2012.

I would now like to turn the call over to Ms.

Susan Hubbard, Vice President of Investor Relations.

Please go ahead.

Thank you, Stacy.

Good afternoon, everyone, and welcome to Gilead's fourth-quarter 2011 earnings conference call.

We issued a press release this afternoon providing earnings results for the quarter and full-year 2011.

This press release is available on our website, as are the slides that provide much more detail around the topics covered on today's call.

I am joined today by our President and Chief Operating Officer, John Milligan, who will review the key milestones and strategic initiatives from 2011; followed by our CFO, Robin Washington, who will provide additional details on our financial results and our 2012 guidance.

Kevin Young, EVP of Commercial Operations, will discuss our commercial performance, and then Norbert Bischofberger, EVP of R&D, will provide an R&D update and key milestones.

John Martin, Chairman and CEO, will close out the prepared remarks by outlining our strategic initiatives for the year ahead.

As a reminder, during today's call, we will be making forward-looking statements regarding our financial outlook, in addition to regulatory and product development plans.

These statements are subject to risks and uncertainties that may cause actual results to differ from those expressed in any forward-looking statement.

A description of these risks can be found in our latest SEC disclosure document and recent press releases.

In addition, please note we undertake no duty to update or revise them.

We will also use non-GAAP financial measures to help you understand our underlying business performance.

The GAAP reconciliations are provided in our press release as well as on our corporate website.

I will now turn the call over to John Milligan.

Thank you, Susan.

Thank you all for joining us today.

Our team's hard work over the last several years resulted in many significant financial, commercial, and R&D milestones in 2011.

We saw record revenues for Atripla, Truvada, AmBisome, Ranexa, Letairis, and Cayston.

We also achieved record market share for our combined HIV portfolio as well as our cardiopulmonary products.

Robin and Kevin will review these outstanding financial and commercial results with you, and then Norbert will describe some of our many R&D accomplishments.

Single tablet regimens are becoming the standard of care for HIV treatment.

And, as you know, it is Gilead's ongoing strategy to provide HIV patients with additional options for simplified regimens.

During the fourth quarter, the European Commission granted approval of the Truvada/rilpivirine single tablet regimen for the treatment of HIV.

This product, marketed in the EU as Eviplera, and as Complera in the US, constitutes our second single-tablet regimen, and began launching in 2011 in the US, Canada, the UK, and Austria.

Regulatory submissions for approval were made in the US and EU during 2011 for Quad, which, if approved, would be Gilead's third single tablet regimen for the treatment of HIV infection.

The NDA was filed less than six weeks after data lock.

These accelerated timelines for collecting and analyzing the data, and filing in both the US and EU, were made possible by the dedication and skill of our R&D teams.

Just two weeks ago, FDA approved lower-strength tablets and an oral powder formulation of Viread for the treatment of HIV-1 infection in pediatric patients from ages 2 to 12.

We are pleased to provide this important therapeutic option for younger HIV patients, and are working to make the pediatric formulations of Viread available in the US and abroad.

For a number of years, we've been collaborating with various organizations to explore the use of Truvada for pre-exposure prophylaxis, or PrEP.

Several studies have shown that the use of Truvada in uninfected, at-risk adults can reduce HIV transmission.

Based on these observations, a supplemental NDA was submitted to FDA in December for the approval of Truvada for prevention of HIV infection among uninfected, high-risk adults.

To get expert advice on this application, FDA is determined that an Advisory Committee meeting for the Antivirals Division will be held in the May timeframe.

We continue to believe that there's room for significant innovation in the area of HIV, and during the year, announced a new collaboration with Tibotec to develop the first single-tablet regimen containing a protease inhibitor.

Tibotec's PI, darunavir, has now been successfully combined into a single pill with emtricitabine and our investigational agents, cobicistat and GS 7340.

We anticipate clinical studies to begin later this year.

In addition, a Phase II study was initiated in the fourth quarter of 2011 for a single tablet regimen containing emtricitabine, elvitegravir, cobicistat, and GS 7340.

Last year, we entered into a licensing agreement with Boehringer Ingelheim, which allowed us to combine BI's patent estate and compounds on non-catalytic site inhibitors for HIV, with our internal research programs.

Integrase inhibitors working by this mechanism are not expected to be cross-resistant to elvitegravir, and we look forward to sharing with you future data on this exciting new class of HIV inhibitors.

On the liver disease front, five-year data from the ongoing open-label phase of our two Phase III clinical studies of Viread for the treatment of chronic hepatitis B were presented at the key US Liver meeting, AASLD.

These data show that five years of Viread treatment did not just halt further progression of fibrosis, but actually resulted in an improvement of liver fibrosis in 51% of patients, and regression of cirrhosis in 74%.

We continue to be enthusiastic about the prospects to help people with chronic HPV by developing finite duration treatments.

With this goal in mind, an exclusive worldwide licensing and collaboration agreement with GlobeImmune was announced in October.

This research is aimed at developing a therapeutic vaccine that will enhance S antigen conversions, providing a functional cure for HPV-infected individuals.

In keeping with our philosophy to develop best-in-class drugs, we acquired Pharmasset in order to bring PSI 7977 to our portfolio.

We anticipate that we'll be able to conduct and complete the clinical studies to allow the first approval of 7977 in combination with rebavirin by FDA during the first half of 2014.

We also plan to initiate the development of alternative 7977-containing regimens, including single tablet regimens with other candidates in our portfolio.

This strategy has the potential to benefit a large number of patients, and provides the opportunity for significant revenue growth and diversification in 2014 and beyond.

Gilead's liver disease team enrolled more than 1400 HCV-infected patients in various clinical studies during 2011, demonstrating their capacity to work towards these accelerated timelines.

In summary, 2011 was a very productive year for Gilead, and I'm very proud of the individual and collective efforts of all our employees.

I will now turn the call over to Robin to discuss in more detail our financial results.

Robin?

Thanks, John.

Good afternoon, everyone, and thank you for joining us.

As John mentioned, we made exciting advances in our products and pipeline programs, and our continued commercial execution delivered solid financial performance in spite of a challenging macroeconomic environment.

For the fourth quarter, product sales were $2.1 billion, an increase of 11% year-over-year.

We completed the year with total product sales at the upper end of our guidance at $8.1 billion, an increase of 10% over the prior year.

At $8.1 billion, we now have a worldwide business that is six times the size we were in 2004, when we first launched Truvada in the United States.

North America product sales for 2011 were close to $5 billion in total, and Europe approached the notable milestone of $3 billion.

Gilead generated product revenues above $200 million in seven countries, and today, has commercial operational capabilities in the US, Canada, Europe, Australia, with a growing presence in South Korea, Hong Kong, Taiwan, and Singapore.

Our fiscal year 2011 non-GAAP product gross margin decreased slightly to 74.8% from 75.8% in fiscal year 2010, primarily due to an annual selling price adjustment for the percentage share of Atripla that is paid to our partner.

This adjustment occurred late in Q4.

Compared to Q4 of the prior year, the selling price adjustment had an unfavorable impact of approximately 2% on our product gross margin.

Non-GAAP R&D expenses for 2011 were $1.1 billion, approximately $19 million above the upper end of our guidance.

This was primarily due to the milestone payment associated with our accelerated registrational filings for Quad in the US and Europe.

In addition to the investments we made in our internal programs over the course of the year, we augmented these efforts through strategic investments and acquisitions, in licensing opportunities and collaborations, which in totality resulted in an additional R&D expenses for the fourth quarter and full year of approximately $60 million and $100 million, respectively.

Our 2011 non-GAAP SG&A expenses were $1.1 billion, in line with our guidance.

When compared to the prior year, non-GAAP SG&A increased, primarily due to expenses associated with the ongoing growth of our business; the US pharmaceutical excise tax expense; and bad debt provisions due to slower collections in certain southern European countries.

Turning to cash flows, for the full year 2011, we generated $3.6 billion of operating cash flow, of which approximately $1 billion was generated in the fourth quarter.

Our track record of generating strong operational cash flows enabled us to raise a total of $5.9 billion in debt to partially fund our acquisition of Pharmasset, while maintaining our investment grade credit rating.

The last financial highlight that I would like to share is our full-year 2012 guidance, which is detailed on slide 23 in the earnings call deck available on our corporate website.

Please note that this guidance is inclusive of the Pharmasset acquisition, which closed in January.

For the full-year 2012, we are projecting product sales of $8.6 billion to $8.8 billion, reflecting a 6% to 9% increase over 2011 product sales.

This range includes the US launch of Quad in the second half of 2012; the growth of Complera and Eviplera in the US and Europe, respectively; the continued gains from our non-HIV products, tempered by the ongoing economic uncertainties in Europe; and the potential for continued volatility in foreign currency exchange rates.

For example, we estimate that a 10% fluctuation in rates for our hedged currencies could have a $150 million to $200 million impact on our product sales.

Please note that the non-GAAP product gross margin and operating expense guidance provided to you include the impact of acquisitions, restructuring, and stock-based compensation-related expenses where applicable.

Our non-GAAP product gross margin for the full-year 2012 is expected to be in the range of 73% to 75%.

We expect non-GAAP R&D expenses for the full year 2012 to be in the range of $1.325 billion to $1.4 billion.

This range includes the full-year operating expense impact of all our recent acquisitions, including Calistoga, Arresto, Oceanside, and most recently, Pharmasset.

We expect non-GAAP SG&A expenses for the full-year 2012 to be in the range of $1.225 billion to $1.3 billion, which includes the anticipated impact of Quad launch and a higher US pharmaceutical excise tax expense.

Our effective tax rate for the full-year 2012 is expected to be in the range of 26% to 28%, due primarily to the expiration of the federal R&D tax credit and the increase in the US pharmaceutical excise tax, which is non-deductible.

As detailed on slide 24, we are anticipating the full-year 2012 diluted EPS impact of acquisitions, restructuring, and stock-based compensation-related expenses to be in the range of $0.31 to $0.34 per share.

And finally, we anticipate the net interest impact associated with the Pharmasset transaction to be approximately $230 million for 2012, which is detailed on slide 25.

I'll now turn the call over to Kevin to share more with you regarding our 2011 commercial performance and our outlook for 2012.

Thank you, Robin.

I am very proud of the many accomplishments achieved by our commercial organization in 2011, and our results in Q4 bode well for a successful 2012.

Especially encouraging were the US Truvada and Atripla Q4 year-on-year growth rates of 9% and 11%, respectively.

These results reflect the final release of 2011 ADAP federal funds and the resultant 50% reduction in patient wait lists from their peak.

HIV product revenues were unaffected by large wholesale inventory levels, and non-retail purchasing was healthy, yet in line with patient demand.

The key patient drivers of HIV growth also looked very encouraging for Q3 2011, our latest data point.

In the US, the moving annual total number of anti-retroviral treated patients remained strong at 9%, and the median CD4 count at treatment initiation hit an all-time high of 347.

We have also been pleased with the uptake of Complera since its US approval and launch in August of last year.

Our goal of bringing the combination products of Truvada and rilpivirine to market was to provide additional options to physicians and expand the total number of HIV patients receiving a single-tablet regimen.

With this in mind, I'm delighted to say that since the launch of Complera, we have seen a 37% growth in the number of prescriptions for patients starting on a single-tablet regimen.

We hope to reproduce this performance in Europe as we roll out Eviplera during 2012.

To date, we have begun supplying Eviplera in the UK, Austria, and Germany.

Over and above our exceptional performance in HIV in 2011, I'm pleased to say that we have a growing business outside our core antiviral franchise.

13% of net product revenues or over $1 billion came from AmBisome, Ranexa, Letairis, and Cayston in 2011.

Importantly, Letairis and Ranexa had year-on-year growth rates of 22% and 33%, respectively.

As I think about 2012, the underlying drivers of HIV commercial growth continue to look robust.

The scientific arguments in HIV to diagnose more patients and treat them earlier have never been stronger.

Moreover, the reasons to be using single-tablet regimens start compelling, both medically and practically.

During 2012, we will continue to rule out Complera around the world, and subject to FDA approval, will bring our third single-tablet regimen to individuals in the US living with HIV.

We feel confident that the Quad will become an important treatment option for HIV patients initiating therapy, and will ultimately be positioned as a preferred therapy in US and international treatment guidelines.

Like the rest of the pharmaceutical industry, we will undoubtedly continue to see some headwinds in European markets.

Nevertheless, the specialist nature of Gilead products, and the strength of the pharma-economic arguments to treat HIV, place us in a strong position for future growth.

We will look for opportunities to open up new operating affiliates, as we have done successfully in recent years in Austria, Switzerland, and Poland, while we see sustainable and profitable businesses and healthcare systems that support breakthrough medicines.

Finally, like the rest of my colleagues, I strongly believe that the acquisition of Pharmasset is a transformational milestone for Gilead.

The worldwide potential for all-oral antiviral pan-genotypic HCV cure is sizable, with over 12 million infected individuals in commercial markets alone.

We are already in high gear preparing global launch plans that will bring GS 7977 expeditiously to patients around the world.

Our established relationships with the hepatologists and gastroenterologists via Viread HBV, our knowledge of liver disease payers and policymakers, and the exciting potential of leveraging our HIV resources to expand HCV provider capacity, is a galvanizing prospect.

And I am confident the Gilead commercial organization will rise to the occasion.

I will now hand the call over to Norbert Bischofberger.

Norbert?

Thank you, Kevin.

For HIV in the fall of last year, we provided positive top-line results from the two pivotal Phase III studies, comparing Quad with two current standard of care regimens, Atripla in Study 102, and that is antibody boosted by ritonavir with Truvada in Study 103.

In both cases, at 48 weeks, Quad proved to be non-inferior to the standard of care regimens.

The 90% response rate observed on the Quad arm in Study 103 is the highest response rate seen in any large blinded randomized study of HIV patients.

The 48-week results for both pivotal studies were accepted for presentation at the Conference on Retroviruses and Opportunistic Infections, or CROI, taking place in Seattle, March 5 through 8.

Study 102 will be the subject of an oral presentation, and Study 103 of a poster.

Across all our HIV programs, that will be at least 45 presentations at CROI highlighting the important role of Gilead products in the treatment of HIV infection.

In the US, the NDA application for Quad has been accepted by FDA for standard review, with a PDUFA date of August 27.

In addition, FDA indicated that a panel would be convened in the May timeframe to provide expert advice on the application.

In Europe, we anticipate that EMEA will complete their review by the end of this year.

To further define the profile of the Quad, we have initiated three 48-week Phase IIIb studies to evaluate switching of virologically-suppressed patients from Atripla to Quad in one study; from Truvada plus a protease inhibitor to Quad in the other; and from raltegravir plus Truvada to Quad in the third study.

We expect data from all three studies to be available by late 2013.

The Quad filing will be followed by regulatory filings this year for the single agents of elvitegravir and cobicistat.

The filing for elvitegravir will be supported by Study 145 comparing elvitegravir to raltegravir in treatment-experienced patients.

96-week data indicating non-inferiority of the two arms were released in 2011.

The cobicistat filing will be supported by Study 114, a Phase III study comparing cobicistat to ritonavir, both in combination with atazanavir and Truvada.

We released top-line results from this study, which also met its 48-week primary objective of non-inferiority.

Last week, we announced initiation of a Phase II clinical trial evaluating GS 7340 for the treatment of HIV infection in treatment-naive adults.

This 150-patient Phase II study will evaluate GS 7340 as part of a once-daily, co-formulated, single-tablet regimen that will also contain cobicistat, elvitegravir, and emtricitabine, and will be compared to our Quad single-tablet regimen.

Moving to cardiovascular, Ranexa appears unique among anti-angina agents, because in addition to reducing ischemia and angina, there is evidence that it also lowers HbA1c, the biomarker for Type II diabetes.

30% to 40% of coronary artery disease patients also have Type II diabetes.

Hence, these patients could potentially derive a dual benefit from Ranexa.

In order to further define this potential benefit, we've initiated a Phase III program that includes three studies enrolling approximately 400 patients each, to determine the effect of Ranexa alone or in combination with other anti-diabetic therapies, in lowering HbA1c and plasma glucose after 24 weeks of treatment.

Confirmation of the anti-diabetic effect of ranolazine in these studies could lead to a new indication of ranolazine for the treatment of Type II diabetes.

Another opportunity for Ranexa is its use in conjunction with percutaneous coronary intervention, or PCI, to prevent subsequent major adverse outcomes.

A subgroup analysis of Merlin, a 7,000-patient study of Ranexa in acute coronary syndrome, indicated that Ranexa treatment resulted in a reduction of major adverse cardiovascular events in patients with a history of angina undergoing PCI.

The Phase III study has started to further define the potential benefit of Ranexa post-PCI.

In this trial, 2,600 patients with a history of angina undergoing PCI with incomplete revascularization, will be randomized to Ranexa or placebo, with the endpoint of major adverse cardiovascular events.

On the oncology front, in further strengthening of R&D management, Roy Baynes has joined the Gilead team as Senior Vice President, Oncology Therapeutics.

Roy joins us from Amgen, where he served as Vice President, Global Development and Therapeutic Area Head for Hematology Oncology.

Throughout his tenure there, over the last decade, he held the Clinical Development and Medical Affairs teams responsible for the approval and launch of numerous hematology and oncology products.

Gilead has acquired promising oncology assets over the last couple of years, and Roy's leadership will be important in bringing these novel candidates to market.

GS 1101 will enter Phase III development this quarter, with studies in chronic lymphocytic leukemia.

In addition, patients are being enrolled in three Phase II studies of the monoclonal antibody GS 6624.

These Phase II studies are evaluating the efficacy and safety of two different doses of GS 6624 in myelofibrosis, pancreatic, and colorectal cancers.

The pancreatic and colorectal cancer studies are both randomized, blinded studies comparing 6624 versus placebo when added to the standard of care in second-line metastatic disease.

In addition, 6624 is also being evaluated in a Phase Ib study in IPF and in a Phase II study for liver fibrosis in HCV-infected patients.

And finally, turning to liver disease, John, Robin, and Kevin have all mentioned the important acquisition of Pharmasset.

We are proceeding with the Pharmasset Phase III development plan for GS 7977 and genotype 2 and 3 patients.

This program consists of two studies -- one in treatment-naive patients who have taken interferon rebavirin as the control arm; the second, in interferon-intolerant ineligible patients with placebo as the control arm.

I'm pleased to report that the treatment-naive study was initiated in mid-December, and since then, we have screened 145 patients.

This trial is the rate-limiting study for filing because of the 24-week duration standard of care arm.

Due to the great interest and fast enrollment, we anticipate that these two Phase III studies will reach target enrollment in the United States before we will be able to activate sites in other geographies.

As you know, results from the ELECTRON Study were presented by Pharmasset at AASLD last October, where GS 7977 and ribavirin for 12 weeks resulted in 10 out of 10 cures in genotype 2/3 patients.

We're awaiting data from multiple studies in genotype 1 patients, specifically from the ELECTRON Study, which enrolled genotype 1, both treatment-naive and null responders, as well as from the QUANTUM Study, which enrolled genotype 1 treatment-naive patients.

We received news this week that our late breaker abstract has been accepted to CROI for two cohorts of genotype 1 HCV-infected patients from the ELECTRON Study, null responders in treatment-naive patients.

In both cohorts of that study, all patients treated with GS 7977 and ribavirin achieved undetectable viral load at four weeks on treatment, also known as rapid virologic response or RVR.

By the time we present those results, we will have four weeks sustained virologic response data, or SVR4, from the null responder patients.

Many of you noticed that it's important to reiterate that RVR reflects virologic response on treatment.

However, the important measure of response in the accepted Phase III endpoint is SVR12, which is a sustained virological response 12 weeks after end of treatment.

SVR4 are a reasonable proxy for SVR12, as most patients that rebound after treatment discontinuation do so in the first four weeks.

We also anticipate that we will have a significant presence at the European Liver Conference taking place in Barcelona in April, with over 17 submitted abstracts from our HCV efforts alone.

As Gilead has pioneered in HIV, we expect to bring forward next-generation single type of regimens for the treatment of hepatitis C also.

To that end, drug interactions will be carried out with 7977 and GS 5885 and other internal candidates, which will be followed by Phase II clinical studies.

In closing, the investments we're making today, both in our broad and promising internal R&D efforts we have embarked upon, will continue to drive the success of our business in the future.

I will now turn over the call to John Martin.

John?

Thank you, Norbert.

As you have heard, we met a number of important milestones in 2011 that were achieved as a result of all the hard work of Gilead employees over the last several years.

This momentum is continuing into 2012.

For HIV, we will continue to benefit from the evolution of the US, European, and international guidelines that support earlier diagnosis and treatment, as well as the growing appreciation for the benefits provided by single-tablet regimens.

In 2006, the Centers for Disease Control and Prevention suggested HIV testing as part of routine medical care in order to decrease the incidence of new infections.

This benefit has now been quantified in Study HPTN 052, demonstrating that HIV treatment results in 96% reduction of HIV transmissions in serial-discordant couples.

The publication of this work in the New England Journal of Medicine was recognized in December as the Breakthrough of the Year by Science Magazine.

The high efficacy demonstrated in HPTN 052 has ended the debate on the value of treatment as prevention.

In summary, we look forward to adding to the strength of our HIV business with our growing pipeline in cardiopulmonary, oncology, and liver disease.

As we enter our 25th year, I believe that the health of our company has never been stronger, with prospects for exceptional growth for many years to come.

At this time, we'll open the call to Q&A.

Stacy?

(Operator Instructions).

Geoff Meacham, JPMorgan.

Thanks for taking the question.

Financial one and then a clinical one.

So for your 2012 guidance, can you let us know if you assume top-line or margin impact from the Quad launch?

And then your currency assumptions in 2012 guidance.

And then for Norbert, just a question here on strategy in genotype 1.

And congrats on the data that you told us today.

But what changes would you guys make in genotype 1 to the original Pharmasset strategy, registration strategy?

Would you increase the number of patients?

Would you increase the -- or change the comparator group?

Just help us out with that.

Thanks.

Hi, Geoff.

So, it's Robin.

I'll answer the financial part of your question.

Yes, we did include the Quad launch as well as the continued uptick of Complera from a product gross margin in our overall guidance.

From an operating margin standpoint, some of that is tempered by the R&D investments that we're making, associated with Pharmasset and the rest of our therapeutic areas.

You also asked about currency.

As I mentioned in the guidance section, the FX assumption is included in that plus or minus 10%.

We believe at our current revenue base is about $150 million to $250 million.

Yes, Geoff, on the clinical side, you know, of course, we've been thinking about the whole different number of scenarios, and many of these depend on what the emerging data looks like.

And that will all become much clearer in the next month or two or three.

And the other thing is we still have to have conversations with regulatory authorities.

But something I can tell you we've been thinking about is to further accelerate the program.

It's entirely conceivable that you would actually -- the studies that will get you approval would be two or three placebo-controlled studies.

So you take the placebo-controlled study in genotype 2/3 that Pharmasset has announced already at the AASLD, and you add to that one or two placebo-controlled studies in genotype 1 for 7977 and ribavirin.

That would probably be an attractive thing for us to do.

But again, of course, it depends on the data in the genotype 1 patients, and secondly, whether the regulatory authorities would agree to that.

And both of those things are being discussed internally, and we have meetings scheduled with regulatory authorities to discuss this.

Thank you very much.

Mark Schoenebaum, ISI Group.

Thanks a lot for taking the question.

I'm going to ask one really boring gross margin question and then one on the HIV franchise.

On the gross margins, if my math is right, it looks like you guys are actually guiding to -- I think your non-GAAP gross margin in 2011 was about 74.5%.

Your guidance is 73% to 75% for 2012.

But Complera is obviously a higher margin product and Atripla is a higher-margin product, so can you help me understand why there wouldn't be more gross margin expansion?

And then Merck today on their call said that ISENTRESS has 14% patient share; but when asked about the impact of the Quad, they seemed to minimize it, because they said that the booster would keep people away from the Quad.

Do you think you can take the 14% patient share away from Merck as low-hanging fruit in the refractory setting?

Thanks.

Mark, I'll take the first part.

So, the margin, to your point, is higher for Complera, but Complera and the launch of the Quad, which wouldn't happen until the second half of 2012, are still relatively small, relative to Atripla.

So while we see some overall upticks, because the variation in the mix of the single-tablet regimen doesn't start to make a huge difference until the out-years of the Quad upticks and Complera upticks.

You'll see more of that in 2013 and 2014.

Okay.

Hey, Mark, it's Kevin on HIV.

We think we've got very attractive potential for Quad.

The results that were referred to by Norbert, I can tell you the awareness of Quad is incredibly high, particularly in the US where we did the majority of our 102 and 103 studies.

And I just think there is such a high and growing demand now for single-tablet regimens.

On slide 36, we bagged a snapshot of Synovate Q4, the Ipsos Healthcare database is actually Synovate, they were bought out.

And so we begged to have a very early look, particularly for Complera.

But you can see already, just in the first quarter, how Gilead single-tablet regimen share has gone up to almost 60% in the naive patients.

I think that shows you that the preference for our single tablets.

So I think having our Quad on the market will only help that.

I do want to point out, though, because our label will be in the naive treatment setting as opposed to treatment-experienced patients for the Quad.

But nevertheless, I think the Quad is, in my mind, going to do very, very well in HIV.

Thank you very much.

Rachel McMinn, Bank of America Merrill Lynch.

Norbert, I just wanted to follow-up on the comments you made with regard to the ELECTRON data at CROI.

Is that 10-patient data sufficient to discuss the Phase III designed with regulators?

Or do you need additional data beyond that?

I assume you do.

And just as a corollary on the R&D budget, just want to get a better sense for this.

Do you -- you have lots of, I assume, increased HCV expenses.

Are you assuming any discontinuation from other pipeline studies?

Or is that something that could impact R&D numbers later after you do a portfolio review?

Thank you.

Yes, Rachel, I will answer the first question.

So the data that we will have by CROI, or will be presenting at CROI, is enough to schedule the meeting with the FDA.

So that's the data that will get us in.

Then to get the meeting data and when the meeting is actually scheduled, which is typically three, four weeks later, then we'll have more data.

That will absolutely suffice to discuss the strategy that we're going to pursue in Phase III in genotype 1 patients.

So, Rachel, it's Robin.

Relative to our R&D guidance, this is a year of investment for us.

To your point, there are incremental investments in liver disease.

There will be some rationalization of the portfolio.

But again, given the transactions closed less than a month ago, we're still going through that process.

And we've basically taken our liver disease program and their program, and we'll do some rationalization, but that won't have an impact until the latter half of the year.

There's also the ongoing investment in oncology and inflammation.

And you have to keep in mind that our study progressions, we have a lot more Phase II and Phase III trials versus prior-year.

So not only in 2012 but also in 2013, you'll see R&D expenses a bit higher.

Rachel, maybe to follow-up on that, we started a large number of Phase II studies last year that looked at relevant questions then.

They are not as relevant any more now.

So we will, of course, discontinue those studies, but it takes a while to close them out.

So as Robin said, the real benefit of closing them out will not be seen in the first half of this year; will more be later.

Thank you.

Matt Roden, UBS.

Thanks for taking the question.

Also a follow-up on Hepatitis C.

Nice to hear that you're going to have the SVR4 data from electronic CROI.

Should we presume that we're going to see SVR12 data at another medical meeting later this year, perhaps at EASL?

And similarly, are we going to see QUANTUM data presented at EASL, or is that simply a top-line press release?

Secondly, just on the financial guidance here, you referred to economic uncertainties in Europe as one of the factors you considered in product sales guidance here, so can you talk about what you're seeing in terms of budgetary constraints to access pricing, receivables, so that we can reflect that in our models as well?

Thanks.

Yes, Matt, I'll answer your first question.

You know, it is our intent that as these data mature, that we will make them public and communicate them, because we have to do that.

We also owe it to the investigators and the patients that they know.

And it helps enrollment in our clinical studies.

But we have not made a decision yet what exactly we're going to present at what meeting.

It depends on really how the data evolve, and what are we going to have at what point in time when the abstract deadline is due.

So we'll decide that when -- at a more short notice.

Hey, Matt, just for further clarity on Europe.

We mentioned just the ongoing uncertainty.

There is an assumption of about a 2% to 3% income -- impact from overall price reductions, which is mostly just part of the ongoing process that happens over there.

And there was a small amount of incremental austerity measures in the latter half of 2011, where we'll see the full-year impact.

Relative to collections, we continue to build up our reserves.

That wouldn't impact revenues, but we staked an increase in bad debt associated with southern Europe into our SG&A guidance as well.

But primarily, if things continue to deteriorate, a lot could happen, as well as it could happen relative to the valuation of the euro.

So we factor that in also.

Thank you.

Yaron Werber, Citi.

So Norbert, just for you, two questions.

One, I mean, the data is looking like it's going to be very good from ELECTRON, both in nulls and in experienced.

So what are your -- I'm sorry naives -- what -- does that mean that you would consider doing one -- you said maybe one to two studies.

Are we talking about maybe a combination naives and nulls?

Or would you actually potentially split it up to a naive and a null study separately?

And then if you don't mind just secondly, just on genotype 2/3, I mean, congrats.

I mean, it looks like the US sites are going to enroll the patients.

Would you consider doing a study for the rest of the world and for genotype 2/3 as well?

Or is that going to be sufficient for global registration?

Yes, thank you, Yaron.

So three comments, three answers to your questions.

So first of all, I would like to remind you again, I know you know this, but the RVR data is necessary but not sufficient.

I want to remind you in the ELECTRON genotype 2/3, they had 100% RVR rates for 7977 by itself but only 60% SVR rate.

So you know we really have to wait for the SVR data.

That's the meaningful thing.

Then the other thing, we're just thinking about -- I mean, this is all dialogue internally -- we could do a study in naive patients in Phase III in genotype 1, and another study in previous treatment failures or rebounders or nonresponders, that would be treatment- naive and treatment-experienced.

And then the other question you asked, yes, absolutely, we are acutely aware of the fact that we have to do studies in other geographies.

It's just that the fact that these studies are going to enroll very, very quickly.

And they will be enrolled way before we have the first site up and running.

But what we are thinking about is doing -- for instance, there's a lot of special population studies that we want to do in parallel.

And those are, for instance, transplant, HIV co-infection, cirrhotics, boceprevir/telaprevir failures.

Those are just four examples.

And those we would look to focus more outside the United States to give people, particularly in Europe, experience with the drug and some comforts to use it, so that they're comfortable once it gets approved.

(multiple speakers) But it's not needed for registration.

So we can absolutely register the drug in the US and probably also in Europe.

We still have to have that conversation with European regulatory agencies with the US studies.

Sapna Srivastava, Goldman Sachs.

Thanks for taking my question.

I actually have two quick questions.

One is, do you have any end of treatment data or SVR trial individual data for patients that we may expect that CROI, are we going to see it all together?

And the second question is, just what do you do with the rest of your HCV portfolio if 7977 stayed out early does live up to this potential at maturity?

Yes, hi, Sapna.

You know the end of treatment data we have now, and they were included at the abstract, so these are the SVR -- the RVR data, but we don't have any SVR data yet.

And those will be presented at CROI and it will be SVR4's.

That's all we're going to have.

But then as I said in my script, SVR4's are a reasonable proxy for SVR12 because they have been at least qualitatively very predictive.

And secondly, what are we going to do with the rest of our HCV portfolio?

Well, 7977 and ribavirin is not going to be our last drug that we're going to get approved in hepatitis C, but we're really aiming for a pan-genotypic single-tablet, oral once-daily regimen.

And that, I think, is much closer than we thought a year ago.

And we have all the compounds internally in place so we can pursue that.

The first one will obviously be 5855 or 7977.

That will probably be genotype 1-specific.

But we have other things coming behind it that have pan-genotypic potential.

Thank you.

Brian Abrahams, Wells Fargo Securities.

Thanks for taking my question.

Another question on 7977, along those same lines.

Kind of a commercial question.

What's your sense as to the SVR rate relative to the current standard of care, that you think would support a go-forward path for 7977 plus riba in the broadest genotype 1 population?

And if you did opt to conduct a pivotal study with 7977 plus 5855 in this broader population, what would be some of the rate-limiting steps to getting to the point of running a pivotal study?

And how far behind would that be versus the genotype 2/3 program?

Thanks.

Yes, Brian, I would like to -- if Kevin wants to chime in, please, do.

So, Brian, you said what is the -- what kind of SVR rates do we need to consider at broad genotype 1 development programs?

You know, I want to remind you there are a lot of people that are interferon ineligible/intolerant.

So even with a not-optimal SVR rate, this would absolutely be a very successful product.

Because let's just pick something -- 30% SVRs.

If there's no downside, you try it for three months, and afterwards, you may have a 30% chance of being cured.

That's a huge step forward from where we are today.

So that's how we're thinking about it.

The other question you had -- I can't remember now.

Is what kind of combo studies.

Oh, what's the rate limiting steps.

So we are currently pursuing a drug interaction study, 7977/5855.

That will then be followed by a fairly small Phase II study to simply show that you can use together -- the two together that you get reasonable SVR rates.

And that would then lead to a Phase III study.

And that's probably about six months to eight months behind 7977 by itself.

Thanks very much.

(multiple speakers)

I wouldn't add much, Brian.

We're very close now to CROI, so in a little over a month, we're going to see that data.

So I think that's going to be very informative.

So I wouldn't really add much to Norbert's comments.

Okay, thanks.

Robyn Karnauskas, Deutsche Bank.

Thanks for taking my question.

I guess some expense questions.

You talked about SG&A being up in 2012.

Maybe you can give us a little sense of what's behind that?

Is HCV the key driver?

Maybe what programs are in education might you be adding ahead of going in to Hep C?

And then second, maybe a little more color on the R&D spend.

Thanks.

Sure.

Robyn, it's Robin.

On the SG&A side, there's a small uptick -- and I'll let Kevin go in a little bit more detail as we prepare for The Quad -- but the biggest impact on SG&A is the excise tax.

So in 2012, we guided to about $50 million and that's pretty much where it came in.

But going forward -- I'm sorry, for 2011.

But in 2012, we expect it to be in a range of $80 million to $100 million.

And that's really driven by about three factors.

One is just our overall growth as -- or our overall revenue growth in the government sector.

Also, the denominator in the calculation is getting smaller, as a result of the decline in the overall pool of pharmaceutical sales, using the calculation as more products go generic.

And then the overall fee is increasing.

So Gilead is getting a bigger component of that tax.

It's a fairly significant increase.

so that's one of the primary drivers.

But I'll turn it over to Kevin to talk about The Quad investment that we're making.

Yes, Robyn, it really isn't HCV.

HCV is mostly, in 2012, around market assessment and building our launch plans.

We are increasing our investments in HIV for the US for the Quad.

Again, that will be very efficient.

We do have a plan, I think, for a high impact launch.

We're certainly not going to leave anything on the table when it comes to the launch of the Quad.

I should also add that we're very carefully establishing our Asian organization.

We hope by the middle of 2012 that we'll have the pricing approval for Viread for HBV in Korea.

Korea is a very substantial market for hepatitis B.

And Tecavir is actually the biggest product of any pharmaceutical in the Korean market and we'd like to be successful there.

So we're being selective and we're being very focused, but we think they're good investments to make around the world.

And Robyn, relative to the color around R&D expense, as I mentioned earlier, Pharmasset is a component of it.

We've pretty much taking their budgets.

The investment in oncology and inflammation is also increasing.

And as also mentioned, it's really a function of more Phase II and III, as we continue to progress our overall pipeline that's driving the increased R&D spend.

Ian Somaiya, Piper Jaffray.

So there's a really nice slide you have, slide 7, which gives us timelines for the HIV products.

I was hoping you could maybe take a shot, Norbert, at the -- on the Hepatitis C side.

I think you've given us some framework for the genotype 2/3.

Can you just comment further on genotype 1 beyond the ribavirin combo and also the 5855?

Yes, Ian, certainly.

I'm actually just looking at slide 7.

I don't think I've ever -- so more -- you want color on which one, on --?

On HCV side.

Well, so genotype 2/3, Ian, as we said, it's kind of its merry way.

So the first study is enrolling.

And as I said, I think, in my conference call, the study was started on December 19 and really not much happened in December because of the holidays.

But nevertheless, we screened, as of this morning, 145 patients.

That's pretty remarkable.

And that's the less attractive study of the two.

They're actually intentionally waiting with the second study so the first gets a little bit underway.

So the study will enroll very quickly.

It's a six-month total study duration, three-months' treatment, three-month follow-up.

We will be able to assemble and analyze the data fairly quickly, and then submit it to the FDA.

And then you can kind of do the math -- it's going to be a very accelerated timeframe.

And genotype 1, if we get -- if the data look good, we will initiate that at the same time the second genotype 2/3 study gets up and rolling.

And genotype 1 will be even faster because there are more patients around.

So I think it's just going to be a very rapid development.

And the 5855 combo?

So we are doing a drug interaction.

We will do a Phase II, a small Phase II study, similar to what 12-week, 7977, 7585 plus/minus ribavirin, something of that sort.

And once we have SVR4 data, I would feel comfortable making a decision to go to Phase III with SVR12 data emerging during that process.

So we were thinking it would be maybe six to eight months behind the 7977 ribavirin program.

Geoff Porges, Sanford Bernstein.

Thanks very much.

A couple of quick questions.

One, Norbert, you mentioned the 7977 monotherapy arm, and the fact that there was four patients who relapsed in that arm at four weeks.

Could you tell us now that you've got 12-week follow-up, how that looked?

And then, just, Robin, could you give us a sense of where we should be thinking about share count going by the end of the year, given all the capital use that you'll have through in the year?

Thanks.

Yes, Geoff, so the ELECTRON, the arm with 7977 by itself still looks the same.

This is not data we have disclosed, but that's one reason why we feel SVR4 is a pretty good proxy for SVR12.

Right.

Thanks.

Geoff, relative to your share count, as we talked about with the acquisition, we did moderate them pretty much to spend our share repurchases after October of 2011.

We will do moderate share repurchases in the near-term to offset option dilution primarily, but our real focus of cash in the near-term is going to be on debt repayment, which we expect to be back at our target debt to EBITDA by mid-2013.

So, to your question on share count, we don't expect it necessarily to go down significantly.

We're just going to try to manage the current balance as much as we can.

Thomas Wei, Jefferies.

I had a question on 7977 and HBV.

So I guess especially now that you've seen 100% RVR rates in genotype 1, we've seen some of what Pharmasset's evaluation assumptions were in their regulatory filings.

What perspective can you share with us or what details are you willing to disclose on the ways in which your own valuation assumptions were similar or different from Pharmasset's?

I guess there's a combined question in there, Thomas.

It's John Milligan.

So a couple things.

Changing a valuation at this point in time wouldn't be prudent because, of course, we don't know what the SVR rates are for genotype 1 or null responders.

And also I think the only thing I can say with regard to our valuation process is that it was very different than the Pharmasset valuation, in terms of how they saw the patient flows and the time of the patients.

So we think it will be a longer timeframe to capture patients than Pharmasset had suggested in their disclosure.

Also I would say that we think there's a lot of patients that can be captured both in the United States, Europe, and other territories, which could provide for a very long and sustained revenue and cash flow stream for Gilead.

But we haven't put out anything more than that.

So that's as much as I can say.

Tom Russo, Robert W.

Baird.

Congratulations on all the progress.

I just had a really quick follow-up.

Can you give us a little bit more color on what you have coming down the pike that's pan-genotypic in addition to 7977?

And also plans down the road for any combinations with those agents?

You know, Tom, we have not disclosed this in any way, but we have a number of backup nucleosides that we, Gilead, has been working on.

And of course, Pharmasset had a number of other nucleosides that are further back.

None of this is clinical yet, so it's still pre-clinical.

But that's what we're looking at.

Okay.

Thanks.

Michael Yee, RBC Capital Markets.

You talked a lot about different combination and a lot of different studies on slide 47 and 48.

I guess I was wondering when you think about long-term, maybe even before 7977 is launched, have you thought about studies with shorter duration regimens or ribavirin-sparing regimens?

Thanks.

Yes, so, Michael, absolutely.

We have not only thought about it but some of these cohorts are already ongoing to look at even shorter duration than 12 weeks, to see what the response rates are there, and to also look at other combination.

I want to remind you we have two important studies ongoing, one with BMS in combination with their NS5A inhibitor with or without ribavirin, and one with Tibotec with TMC 435.

Both of those look at general combinations of 7977 with other agents and will provide important information about how to use the drug optimally.

And by the way, both of those studies, the BMS study is, you could say, also explores ribavirin's bearing, because the arms are 7977 plus the BMS NS5A plus or minus ribavirin.

So it has both two drugs and three drugs in the regimen.

Can you comment when you think we could see data from that?

No, really not because that study is conducted by BMS and they have control over the data assembly and release.

Okay.

Thank you.

Ravi Mehrotra, Credit Suisse.

A question for Kevin.

Kevin, can you give us any color on the proportion of treatment-naive patients versus treated patients for Complera and how that's changed over these very early phases of launch.

Second part to that question, you cited the protease inhibitor -- sorry -- the PI study is due, the 420 patients is due to report out in Q2.

How quickly can you get that into the label?

Hey, Ravi, thanks for a little bit of love for commercial here.

I knew I could count on you.

Yes, I certainly can give you a little bit.

And obviously, it's only four months of data.

So it's really very, very early for Complera.

If you break down where the patients are coming from for Complera, about 30% are naive and about 70% are switch.

And of the switch, about one-third were switches from the Atripla; and two-thirds were switches from other regimens.

And I think you can see that going out a little bit in the slide I referred to earlier, which is that very nice early snapshot of Q4.

Because you can see that actually Truvada has dropped down a little where you see Complera coming in.

But obviously, when you total both Atripla and Complera, you get up to about 59%.

So a little bit of the trade-off has obviously been Truvada plus something else, but we're okay with that because we want to have patients onto the single-tablet regimens.

In terms of the inclusion of the data, Norbert, how long would it be typically for us to look for some sort of label change if we submitted data --?

The study is fully enrolled.

I don't have the last patient, last visit here, but normally, what you would -- the intern, and if we look at three to six months to collect, analyze, write up the data, submit them, and this will probably be a six-month review efficacy supplement.

So you're looking at maybe a year after completion of the 48-week endpoint.

That's great.

Thanks.

Phil Nadeau, Cowen and Company.

Thanks for taking my questions.

Norbert, back to you.

I was just wondering if you could put a finer point on a couple of things you said.

So first, on the FISSION trial, it sounds like in a month, you've enrolled maybe a little bit less than one-third of that study.

If I assume that that enrollment is going to actually increase with time, that means that trial could actually be enrolled by the end of this quarter.

It's a 36-week study, so is it reasonable to expect data from that possibly year-end this year or very early in 2013?

So if your calculation is correct, then yes, that's reasonable to expect that.

You know, the other -- I just want to point out two things.

Actually, we haven't enrolled 145.

We've screened 145.

There will be a certain screen failure rate, although we don't expect that to be high.

The other thing is also, there aren't a lot of the sites up and running yet.

We were thinking about having a large number of sites.

With only 19 sites open in the short period of time -- we have 145 screened.

So enrollment will be very quick.

I do not really want to predict how quick, but soon thereafter -- six months afterwards, nine months afterwards, it's the end of this study.

Remember the control arm is PEG/riba, 24 weeks, so it's a nine-month observation period.

And after that, yes, you could submit certainly an abstract to a meeting.

Okay.

And then second, on your comments on starting the genotype 1 trial, and the answer to two separate questions.

At one point you said even like a 30% SVR would be perhaps meaningful for patients.

And then in an answer to another question, you said if the data looked good, we're going to start the genotype 1 study kind of at the same time as POSITRON.

Can we take from that basically if there's any SVRs that come out of ELECTRON and QUANTUM and genotype 1 patients, the genotype 1 study is going to start?

It sounds like the bar to starting that genotype 1 trial is actually quite low.

Is that fair?

Well, you know, at one point, of course, if you get to very low numbers, then we wouldn't be doing it because we don't need to go there.

We have 5885 and 7977 that about six months afterwards.

And that -- if 7977 and ribavirin doesn't -- is not enough in genotype 1 by itself, then adding 5885 will certainly greatly increase those response rates.

And we then just have to gauge what is the loss and time, and the risk and the expenses associated with it.

Could you give us some idea what the bar is?

Is it 30%, 50%, 80%?

Like what would be the go/no go point in your mind?

No, you know, we really don't see it that way that we say, you know, below 30%; we don't do it above 30%.

We do 50%, we do -- we just -- we have to really look at the totality of the data.

Another thing, of course, is also you have to look at resistance.

Those that don't respond, rebounders or null responders, if there are any -- well, there aren't any right now, but if there were -- those people develop resistance.

And if the answer is no, then you could say there's really no downside to treating somebody.

The only downside practically is cost.

It's safe, well-tolerated.

It's only for three months.

It's oral, it's convenient.

Why, if you're at 30% response rates, it seems to me, why wouldn't a patient accept that as a reasonable alternative to what's currently available.

Great.

Thanks for taking my questions.

Brian Skorney, Brean Murray.

Congratulations on the data and a good quarter.

Just real quick, a couple of questions.

The first one, on slide 45 on the ELECTRON cohorts, you have all the cohorts listed as having an [N of] 10, but on the last Pharmasset slide set in Dr.

Gane's ELECTRON presentation, there were 25 patients supposed to be enrolled in the treatment-naive cohort and the 2/3 experienced cohort.

Has this protocol changed?

No, actually, Brian, that -- I'm just seeing the slide right now.

That is not correct.

There are two -- those two cohorts, that's 25 patients target enrollment.

That's correct.

Yes, Brian, that's actually a really good catch.

Thank you.

We missed that.

Okay.

Fair enough.

And then the second question is just moving on to the Quad, I wonder if you guys have any thoughts on Ad Comm?

I mean, it just seems like the FDA has less frequently used Advisory Committees where there wasn't really controversy around, whether or not to approve.

I just wonder, has the FDA communicated any rationale for why they're going to have an Ad Comm for the Quad specifically?

Yes, absolutely, Brian.

We actually had a conversation with them when they informed us of their intent to do an Ad Comm.

We said, why do we need one?

And they referred us to a guidance document that's available on the FDA website.

And it clearly says FDA Advisory Committee meetings can be convened or should be convened if it's a first-in-class molecule.

And the FDA felt fairly strongly that cobicistat, in particular, was something that's first-in class, one of its kind, and that's why they wanted to do it.

But they also communicated to us that there is no safety or efficacy concern with the Quad that would make them feel like they need an Advisory Committee.

So it's more of a policy thing that has to do with first-in-class, one of its kind molecules.

In cobicistat, that is the one that's in The Quad.

Right.

Thanks, guys.

Jim Birchenough, BMO Capital Markets.

A couple of maintenance questions.

Just on the R&D spend, it seems like we get a spike every fourth quarter, at least for the last couple of years.

Could you remind us why that is?

And should we expect the same distribution in 2012?

And then just on the Quad, as it's part of your guidance, are you assuming a similar launch trajectory as what we've seen for Complera?

And would something better than that be upside to guidance or --?

I'm just trying to get a sense of how you're thinking about Quad out of the gate compared to what we've seen from Complera.

Thanks.

Hey, Jim, it's Kevin.

I'll take the second part first in terms of the possible uptake of Quad.

Just to step back.

If you think about Complera, Complera was never going to be Atripla.

There just weren't no existing patients; there was no conversion market like we have with Atripla.

Atripla had 80,000 patients on the components when we came out the gates.

And obviously, that gave it an incredible ramp-up.

We never had that; never said we would have that with Complera.

So in some ways, Complera is almost like a third agent launch.

And that's why, on slide 35, I referred to our volume being above Prezista as a sort of a third-agent comparator, which we're pretty pleased with.

I think, at this stage, I would probably peg the launch of the Quad somewhere between an Atripla and a Complera.

As I said earlier, there's a high expectation for Quad, very high knowledge of it and a very strong investigator base.

So we believe that there is a high expectation.

And I think we believe that we would get to preferred listing, a preferred ranking for Quad based on 102 and 103 data.

We never expected to be a preferred regimen and treatment guidelines with Complera.

But we are hopeful that that would happen fairly quickly with Quad.

And obviously, that's a big market driver.

And Jim, to the first part of your question, the spikes that you refer to are really just driven by milestone payments; or in the case of 2011, was primary related to some of the M&A and the collaboration activity that we did in Q4.

It was to the tune of $60 million is what I caught on in our script.

And that included the Boehringer Ingelheim agreement as well as global immune.

And then the other piece related to the timing of the Quad filing.

So again, that's what the driver was.

Those aren't always predictable.

When you think about 2012 and the way we planned it is, it's pretty much straight line.

But those milestones can occur from time to time.

Great, thanks.

Our next question is our final question, coming from the line of Mark Schoenebaum with ISI Group.

Please proceed.

Oh, wow, thanks for taking the follow-up.

I really appreciate it.

Hey, just to follow-up to Brian's question.

I just want to be really clear.

So 25 patients in the ELECTRON cohorts, but 10 -- you reported today RVR data on 10 of them.

Is that correct?

Yes or no.

And then just to make sure we're all clear.

And then will you have data on all 25 patients at CROI -- some kind of data for all 25 patients, perhaps RVR data for the ones that you don't have SVR data for?

Yes, so Mark, to be clear, the abstract was submitted with all available RVR data, which comes from both cohorts, the treatment-naive and null responders from ELECTRON.

But at the time of the CROI presentation, we will only have SVR4 on the null responders.

That's a total of 10.

There won't be any other SVR data.

Those patients just aren't as far along at that point in time.

So that's what we're going to have.

Thanks and congrats on the data.

Ms.

Hubbard, at this point, we have run out of time for additional questions.

Great.

Thank you, Stacy, and thank you all very much for joining us today.

We very much appreciate your continued interest in the Company, and we look forward to providing you with updates on our exciting milestones as we head through 2012.

We thank you for your participation in today's conference.

This does conclude your presentation.

You may now disconnect and have a great day.